This job is now closed
Job Description
- Req#: 381006
- Develop and execute the strategic vision and roadmap for the vaccine drug substance manufacturing value stream.
- Lead a team of manufacturing professionals, engineers, and support staff, providing guidance and mentoring to ensure efficient and effective vaccine manufacturing operations and delivery.
- Promote a highly conscious EHS culture and focused workforce for safety, sustainability, and employee well-being.
- Identify and analyze value stream processes, workflows, and operational metrics to improve processes and implement best practices for vaccine drug substance manufacturing.
- Collaborate with cross-functional teams, including EHS, R&D, MSAT, Quality Assurance, Quality Control, Supply Chain, and Engineering to drive operational efficiency, product quality, and regulatory compliance.
- Establish performance metrics and key performance indicators (KPIs) to track and monitor the performance of the vaccine manufacturing value stream, ensuring compliance with production targets, quality standards, and customer requirements.
- Identify and implement technological solutions, automation, and digital tools to streamline manufacturing operations, enhance product quality, and improve workflow efficiency.
- Ensure compliance with regulatory requirements, Current Good Manufacturing Practices (cGMP), and quality standards in vaccine manufacturing. Ensure inspection readiness state at all times.
- Lead organizational changes to continuously deliver improved results in the areas of quality, right first time, and on-time in full delivery of drug substance.
- Bachelor's degree in a relevant scientific or engineering discipline, such as Chemical Engineering, Biotechnology, or Pharmaceutical Sciences.
- 10+ years of direct experience in pharmaceutical or biopharmaceutical manufacturing environment.
- 5+ years of direct pharmaceutical or biomanufacturing senior leadership at the site level.
- Experience planning, leading, and overseeing cGMP downstream processes.
- Experience using manufacturing information systems, automation technologies, and other relevant software applications.
- Excellent analytical and problem-solving skills, with the ability to collect and interpret data to drive decision-making and process optimization.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels of the organization.
- In depth knowledge of cGMPs, regulatory and quality requirements for Biologics or Vaccines,
- Demonstrated interpersonal and leadership skills. The ability to function within a multidisciplinary environment (including EHS, QA, MSAT, Supply Chain, QC, and Engineering) and lead the process, generate the exchange of ideas to resolve problems, prioritize and select optimal solutions and implement decisions.
- Demonstrated ability to lead change initiatives, influence stakeholders, and drive a culture of continuous improvement in a manufacturing environment.
- Proactive mindset with the ability to prioritize tasks, manage multiple projects, and adapt to evolving priorities and challenges.
- Experience in commercial vaccine manufacturing is highly desirable.
- Knowledge of regulatory guidelines for vaccine manufacturing, technology transfer, and process validation is desirable.
Are you energized by a highly visible role that allows you to influence stakeholders and shape highly effective business partnerships? If so, our Director, Manufacturing role could be an excellent opportunity to explore!
As Director, Manufacturing, you will be responsible for the Binney Street MAPS Drug Substance Value Stream. You will engage at a leadership level across the business unit to meet the organizations expectations for Safety, Quality, Supply, Cost and creating a culture where employees are fully engaged with high job satisfaction. You will be responsible for delivering the supply plan for the MAPS drug Substance. You will be a member of the Senior Leadership team, reporting into the site lead.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Why GSK?
By 2031, we aim to deliver more than £33 billion in annual sales – a step-change in performance and growth which will significantly increase the positive impact we can have on the health of billions of patients around the world. And we’re confident in our future.
Since 2017, we’ve delivered 13 major approvals and more than doubled the number of potential new vaccines and medicines in Phase 3 and registration to 23. Our pipeline of 21 vaccines and 43 medicines includes many with potential to be first or best-in-class opportunities for patients.
In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.
GSK’s portfolio spans three product areas: vaccines, specialty and general medicines and our focus is to deliver better and faster for patients globally. We’re prioritising investment in vaccines and specialty medicines, which we expect to grow to around three quarters of our business in the next five years.
Our unrivalled vaccine portfolio targets infectious diseases at every stage of life, helping to reduce the burden of disease for hundreds of millions of people. GSK has exceptional capabilities in vaccine science and technologies, including adjuvant/protein and mRNA.
In specialty medicines, we are at the forefront of HIV prevention and treatment, and we are building our presence in key therapeutic areas such as oncology and immuno-inflammation.
General medicines include our inhaled medicines for asthma and COPD, antibiotics and medicines for skin diseases.
Every day, GSK medicines and vaccines protect and improve health, making life better for millions of people all over the world.
#LI-GSK
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
About the company
GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England.
Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000.
Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility.
An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report. NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.